Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement (STERILE)
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Details and patient eligibility
About
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Patient is at least 18 years of age
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Patient is planned to undergo at least one of the following procedures:
a) Patient has existing CIED (pacemaker, or CRT-P, or ICD, or CRT-D) and is undergoing pulse generator replacement or upgrade with a new generator. b) Patients planned to have leads added, or extracted and added for upgrades.
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Patient is willing to sign and date informed consent
Exclusion criteria
- History of CIED-related infection
- Open the pocket for any reason within the last one year
- Any evidence indicating active infection
- Requirement of long term vascular access for any reason
- Expected survival time is less than one year
- Patients who were pregnant or breastfeeding
- Participation in another study that may confound the results of this study
- Patient is unable to comply with scheduled follow up
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,016 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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